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COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss (COVAYDE)

Primary Purpose

Coronavirus Infection, COVID, Severe Acute Respiratory Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Awake Prone Positioning
Standard care
Sponsored by
Hôpital de Verdun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring SARS-CoV-2, SARS-CoV-2 infection, COVID-19, HFNC, HFNO, Proning, Prone position, High-flow nasal cannula, High-flow nasal oxygenation, Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COVID-19, either confirmed by SARS-CoV-2 assay, or clinically suspected, with results of the assay pending;
  • Lung infiltrates documented on chest X-ray or chest CT-scan;
  • Significant respiratory distress that requires treatment with HFNO.

Exclusion Criteria:

  • Unable to consent;
  • Unable to prone;
  • Indication for immediate endotracheal intubation and mechanical ventilation;
  • Contraindication to prone positioning (severe obesity, abdominal wound, pregnancy, unstable pelvic/spinal lesions, vomiting, etc.);
  • Comfort care or imminent expectation of death.

Sites / Locations

  • Hôtel-Dieu de Gaspé
  • Hôpital de la Cité-de-la-Santé
  • Montreal General Hospital, McGill University Healthcare Center
  • Royal Victoria Hospital, McGill University Healthcare Center
  • Hôpital de Verdun

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Awake prone positioning

Standard care

Arm Description

Prone positioning of patients on nasal high-flow oxygen therapy

Standard decubitus positioning of patients on nasal high-flow oxygen therapy

Outcomes

Primary Outcome Measures

Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death

Secondary Outcome Measures

Intubation rate
Mortality
Days spent on mechanical ventilation
Days spent in the ICU
Hospital stay (in days)

Full Information

First Posted
May 15, 2020
Last Updated
March 21, 2021
Sponsor
Hôpital de Verdun
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1. Study Identification

Unique Protocol Identification Number
NCT04395144
Brief Title
COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss
Acronym
COVAYDE
Official Title
Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital de Verdun

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, COVID, Severe Acute Respiratory Syndrome, Respiratory Failure, Respiratory Insufficiency, Respiratory Distress Syndrome, ARDS, Lung Diseases
Keywords
SARS-CoV-2, SARS-CoV-2 infection, COVID-19, HFNC, HFNO, Proning, Prone position, High-flow nasal cannula, High-flow nasal oxygenation, Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Awake prone positioning
Arm Type
Experimental
Arm Description
Prone positioning of patients on nasal high-flow oxygen therapy
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Standard decubitus positioning of patients on nasal high-flow oxygen therapy
Intervention Type
Procedure
Intervention Name(s)
Awake Prone Positioning
Intervention Description
Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h
Intervention Type
Procedure
Intervention Name(s)
Standard care
Intervention Description
Patients will not receive any special instructions with regards to proning.
Primary Outcome Measure Information:
Title
Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death
Time Frame
Up to 28 days after randomization
Secondary Outcome Measure Information:
Title
Intubation rate
Time Frame
Up to 28 days after randomization
Title
Mortality
Time Frame
Up to 28 days after randomization
Title
Days spent on mechanical ventilation
Time Frame
Until discharge, up to 24 weeks after randomization
Title
Days spent in the ICU
Time Frame
Until discharge, up to 24 weeks after randomization
Title
Hospital stay (in days)
Time Frame
From admission to discharge, up to 24 weeks after randomization
Other Pre-specified Outcome Measures:
Title
Time in prone position
Description
Total time spent in prone position, as recorded by nursing or respiratory therapists
Time Frame
Up to 28 days post randomization
Title
Oxygenation (SpO2/FiO2 ratio)
Description
Daily evolution of oxygenation
Time Frame
Until HFNC weaning, or up to 14 days after randomization, whichever is first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COVID-19, either confirmed by SARS-CoV-2 assay, or clinically suspected, with results of the assay pending; Lung infiltrates documented on chest X-ray or chest CT-scan; Significant respiratory distress that requires treatment with HFNO. Exclusion Criteria: Unable to consent; Unable to prone; Indication for immediate endotracheal intubation and mechanical ventilation; Contraindication to prone positioning (severe obesity, abdominal wound, pregnancy, unstable pelvic/spinal lesions, vomiting, etc.); Comfort care or imminent expectation of death.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Pavlov, MD
Organizational Affiliation
Hôpital de Verdun
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôtel-Dieu de Gaspé
City
Gaspé
State/Province
Quebec
ZIP/Postal Code
G4X 2W2
Country
Canada
Facility Name
Hôpital de la Cité-de-la-Santé
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Montreal General Hospital, McGill University Healthcare Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Royal Victoria Hospital, McGill University Healthcare Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Hôpital de Verdun
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4G2A2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34425070
Citation
Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
Results Reference
derived
PubMed Identifier
33177145
Citation
Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.
Results Reference
derived

Learn more about this trial

COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss

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